MULTACHOICE INSTRUMENTS— 510(k) K991814

Substantially Equivalent

Dexide, Inc.

FDA 510(k) clearance K991814 for MULTACHOICE INSTRUMENTS, Substantially Equivalent on 1999-06-23. Applicant: Dexide, Inc..

Clearance details

Applicant
Dexide, Inc.
Product code
Code GEI
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Fort Worth, TX, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code GEI

product code GEI
Death
133
Injury
7,585
Malfunction
35,808
Other
44
Total
43,570

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.